Trial Review

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Intervention Group 1: Perna canaliculus (green lipped muscle) – capsule form (50mg per capsule). Dosage 2 oral capsules in the morning and evening with meals for eight weeks prior to the down hill run and for three days after.

Intervention Group 2: Harpagophytum procumbens (Devil’s Claw) – liquid form (500mg per millilitre). Dosage 10ml orally daily for six weeks prior to the down hill run and four days after.

Intervention Group 3: Arnica Gel (10mg per gram) – topical application, directions to rub into the quadriceps straight after the down hill run and then every four hours (excluding sleeping hours) for five consecutive days.

Intervention Group 4: Tienchi ginseng – oral tablet form (1000mg per tablet). Dosage 4 tablets, four times daily. Taken 1 hour prior to the down hill run and then for the next consecutive four days.

The down hill run consists of 5 bouts of 8 minute down hill running (-10% gradient) with 2 minute rest intervals walking on the flat.

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Intervention code [1]34930

Prevention

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Comparator / control treatment

Control Group 1 - Placebo in 50mg capsule form containing olive oil. Dosage is 2 oral capsules in the morning and evening with meals for eight weeks prior to the down hill run and for three days after.

Control Group 2 - Placebo in 500ml liquid form containing 45% ethanol, coloured and flavoured with gentian, chocolate brown colour and permacol black. Dosage 10ml orally daily for six weeks prior to the down hill run and four days after.

Control Group 3 – Placebo tube of clear base gel for topical application. Directions: rub into the quadriceps straight after the down hill run and then every four hours (excluding sleeping hours) for five consecutive days.

Control Group 4 – Placebo in oral tablet form (containing, calcium & magnesium salts, microcrystalline cellulose, sodium starch glycollate, colours & flavours). Dosage 4 tablets, four times daily. Taken 1 hour prior to the down hill run and then for the next consecutive four days.

The down hill run consists of 5 bouts of 8 minute down hill running (-10% gradient) with 2 minute rest intervals walking on the flat.

Identification of changes in the blood markers that may indicate inflammation and muscle degeneration. Blood analysis to identify the presence of muscle damage markers include Creatine Kinase and Myoglobin, Acute Phase Response Markers include Interleukin-1, Interleukin-6, Tumour Necrosis Factor-? and C-Reactive Protein that may indicate inflammation.

Procedure for enrolling a subject and allocating the treatment (allocation concealment
procedures)

At session 1 (-6 weeks) all eligible participants will complete a beep test session which will be used to match subjects according to their DOMS response and anthropometric data (height, weight, body mass index, activity and training history). This will enable matching of participants before randomisation to minimise inter-individual variability. Participants will then be randomly assigned active or placebo medication by a computerised random number generator and matched up by an independent party to allow double blinding.

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Methods used to generate the sequence in which subjects will be randomised (sequence
generation)

Randomisation will be conducted by computer. Patients and investigating staff will be blinded to treatment allocation.

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Masking / blinding

Blinded (masking used)

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Who is / are masked / blinded?

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Intervention assignment

Parallel

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Other design features

Placebo controlled and four treatment arms.

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Phase

Phase 2

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Type of endpoint(s)

Efficacy

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Statistical methods / analysis

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Recruitment

Recruitment status

Completed

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Date of first participant enrolment

Anticipated

1/01/2005

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Actual

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Date of last participant enrolment

Anticipated

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Actual

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Date of last data collection

Anticipated

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Actual

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Sample size

Target

96

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Accrual to date

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Final

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Recruitment in Australia

Recruitment state(s)

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Funding & Sponsors

Funding source category [1]39590

University

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Name [1]39590

University of Western Sydney

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Address [1]39590

Locked Bag 1797Penrith South DCNSW 1797

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Country [1]39590

Australia

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Funding source category [2]39600

Government body

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Name [2]39600

Australian Institute of Sport

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Address [2]39600

PO Box 176BelconnenACT NSW 2616

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Country [2]39600

Australia

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Primary sponsor type

University

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Name

University of Western Sydney

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Address

Locked Bag 1797Penrith South DCNSW 1797

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Country

Australia

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Secondary sponsor category [1]35510

Government body

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Name [1]35510

Australian Institute of Sport

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Address [1]35510

PO Box 176BelconnenACT NSW 2616

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Country [1]35510

Australia

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Ethics approval

Ethics application status

Approved

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Ethics committee name [1]60280

University of Western Sydney Human Research Ethics Committee

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Ethics committee address [1]60280

Locked Bag 1797Penrith South DCNSW 1797

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Ethics committee country [1]60280

Australia

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Date submitted for ethics approval [1]60280

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Approval date [1]60280

15/07/2004

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Ethics approval number [1]60280

HREC04/158

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Ethics committee name [2]60290

Australian Institute of Sport Ethics Committee

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Ethics committee address [2]60290

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Ethics committee country [2]60290

Australia

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Date submitted for ethics approval [2]60290

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Approval date [2]60290

20/08/2004

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Ethics approval number [2]60290

20040805

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Summary

Brief summary

Delayed Onset Muscle Soreness (DOMS) and muscle damage are common and expected self-limiting sports training related conditions that can result in a loss of muscle force and significant pain. For athletes required to train and compete in close succession, DOMS can pose an obstacle to optimal performance. At present there are multiple methods for treating DOMS. Methods include; cryotherapy, anti-inflammatory medications, stretching, hypo-baric oxygen therapy, homeopathy, ultrasound, E-stimulation, L-carnitine, rest and light exercise. To date, a sound and consistent treatment for DOMS has not been established.

High-quality scientific research into Complementary and Alternative Medicines (CAM) and DOMS is limited despite the increase usage of such products by athletes. This is a randomised, double blind, placebo controlled trial that looks at four selected CAM’s in four sub-studies and their effect on DOMS and muscle damage in sub-elite athletes.